BioDuro-Sundia

Overview

BioDuro-Sundia, an Advent International portfolio company, is a leading global contract research, development, and manufacturing organization (CRDMO) with over 28–30 years of proven expertise. Headquartered in Irvine, California, the company employs more than 2,000 scientists and provides fully integrated drug discovery and development services spanning small-molecule and large-molecule modalities.

Core Service Capabilities

Discovery Services

• Chemistry: Medicinal chemistry, parallel synthesis, peptide chemistry, computational chemistry, synthetic chemistry, analytical chemistry, scale-up chemistry, and fragment-based drug discovery (FBDD)
• DMPK: In vivo PK/TK, in vitro ADME, bioanalytical services, exploratory toxicity in rodents/dogs/monkeys, and large-molecule development and bioanalysis
• Biology: Assay development and platform technologies (biochemical, cellular, ligand binding assays), protein science, surface plasmon resonance (SPR), safety pharmacology, and screening services
• Oncology Models: PDX, CDX, orthotopic, syngeneic, humanized mouse, CAR-T/CAR-NK mouse models, ELISA and in vitro assays
• Pharmacology: Immunology & inflammation, metabolic, MASH mouse models, respiratory, and neuroscience

Development & Manufacturing

• Drug Substance: Process R&D (flow chemistry, sugar chemistry, peptide chemistry, preparative purification, process safety assessment), scale-up synthesis, and kilo/pilot-scale API manufacturing
• Drug Product: Preformulation, formulation development, hot-melt extrusion (HME), spray-dried dispersion (SDD), amorphous solid dispersion, bioavailability enhancement, and modified-release manufacturing
• IND-Enabling Platforms: Antibody-drug conjugate (ADC) development, peptide compound management, PROTAC solution engine, and DNA-encoded library services

Strategic Positioning

BioDuro offers a "one-stop shop" platform integrating preclinical research, chemistry, biology, DMPK, and comprehensive IND-enabling capabilities. The company has recently announced a strategic partnership with CTI Biotechnology to strengthen GLP toxicology and bioanalytical services, further enhancing its integrated discovery-to-IND submission platform for global biotech and pharmaceutical clients.